Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study

Bell's palsy is a rare adverse event reported in clinical trials of COVID-19 vaccines. However, to our knowledge no population-based study has assessed the association between the inactivated SARS-CoV-2 vaccines and Bell's palsy. The aim of this study was to evaluate the risk of Bell'...

Full description

Saved in:

Bibliographic Details
Published in:	The Lancet infectious diseases Vol. 22; no. 1; pp. 64 - 72
Main Authors:	Wan, Eric Yuk Fai, Chui, Celine Sze Ling, Lai, Francisco Tsz Tsun, Chan, Esther Wai Yin, Li, Xue, Yan, Vincent Ka Chun, Gao, Le, Yu, Qiuyan, Lam, Ivan Chun Hang, Chun, Raccoon Ka Cheong, Cowling, Benjamin John, Fong, Wing Chi, Lau, Alexander Yuk Lun, Mok, Vincent Chung Tong, Chan, Frank Ling Fung, Lee, Cheuk Kwong, Chan, Lot Sze Tao, Lo, Dawin, Lau, Kui Kai, Hung, Ivan Fan Ngai, Leung, Gabriel Matthew, Wong, Ian Chi Kei
Format:	Journal Article
Language:	English
Published:	United States Elsevier Ltd 01-01-2022 Elsevier Limited
Subjects:	Adolescent Adult Adverse events Age Aged Aged, 80 and over Bell Palsy - epidemiology Bell Palsy - etiology Bell's palsy Bells palsy BNT162 Vaccine - adverse effects Case studies Case-Control Studies Clinical trials Coronaviruses COVID-19 COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - adverse effects Data analysis Deactivation Electronic health records Electronic medical records Equivalence FDA approval Female Health Personnel Health surveillance Hospitals Humans Immunization Incidence Infectious diseases Life sciences Male Middle Aged mRNA mRNA vaccines Paralysis Population Population studies Professional ethics Proprietary Risk assessment Severe acute respiratory syndrome coronavirus 2 Steroids Translation Vaccination - adverse effects Vaccines Vaccines, Inactivated - adverse effects Young Adult Hong Kong China China Israel
Online Access:	Get full text
Tags:	Add Tag No Tags, Be the first to tag this record!

Description
Summary:	Bell's palsy is a rare adverse event reported in clinical trials of COVID-19 vaccines. However, to our knowledge no population-based study has assessed the association between the inactivated SARS-CoV-2 vaccines and Bell's palsy. The aim of this study was to evaluate the risk of Bell's palsy after BNT162b2 and CoronaVac vaccination. In this case series and nested case-control study done in Hong Kong, we assessed the risk of Bell's palsy within 42 days following vaccination with BNT162b2 (Fosun–BioNTech [equivalent to Pfizer–BioNTech]) or CoronaVac (from Sinovac Biotech, Hong Kong) using data from voluntary surveillance reporting with the Hospital Authority, the COVID-19 Vaccine Adverse Event Online Reporting system for all health-care professionals, and the Hospital Authority's territory-wide electronic health records from the Clinical Data Analysis and Reporting System. We described reported cases of Bell's palsy among vaccine recipients (aged 18–110 years for CoronaVac and aged 16–110 years for BNT162b2). We compared the estimated age-standardised incidence of clinically confirmed cases among individuals who had received the CoronaVac or BNT162b2 vaccination (up to 42 days before presentation) with the background incidence in the population. A nested case-control study was also done using conditional logistic regression to estimate the odds ratio (OR) for risk of Bell's palsy and vaccination. Cases and controls were matched (1:4) by age, sex, admission setting, and admission date. Between February 23 and May 4, 2021, 451 939 individuals received the first dose of CoronaVac and 537 205 individuals received the first dose of BNT162b2. 28 clinically confirmed cases of Bell's palsy were reported following CoronaVac and 16 cases were reported following BNT162b2. The age-standardised incidence of clinically confirmed Bell's palsy was 66·9 cases per 100 000 person-years (95% CI 37·2 to 96·6) following CoronaVac vaccination and 42·8 per 100 000 person-years (19·4 to 66·1) for BNT162b2 vaccination. The age-standardised difference for the incidence compared with the background population was 41·5 (95% CI 11·7 to 71·4) for CoronaVac and 17·0 (−6·6 to 40·6) for BNT162b2, equivalent to an additional 4·8 cases per 100 000 people vaccinated for CoronaVac and 2·0 cases per 100 000 people vaccinated for BNT162b2. In the nested case-control analysis, 298 cases were matched to 1181 controls, and the adjusted ORs were 2·385 (95% CI 1·415 to 4·022) for CoronaVac and 1·755 (0·886 to 3·477) for BNT162b2. Our findings suggest an overall increased risk of Bell's palsy after CoronaVac vaccination. However, the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of this generally self-limiting adverse event. Additional studies are needed in other regions to confirm our findings. The Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, China. For the Chinese translation of the abstract see Supplementary Materials section.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Co-first authors. EYFW and CSLC contributed equally to this Article
ISSN:	1473-3099 1474-4457 1474-4457
DOI:	10.1016/S1473-3099(21)00451-5